GILENYA®
Fingolimod hydrochloride
Consumer Medicine Information (CMI)
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Gilenya. It does not contain all the information that is known about Gilenya. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Gilenya is used for
Gilenya is a new type of medicine known as sphingosine 1-phosphate (S1-P) receptor modulators. The active substance of Gilenya is fingolimod.
Gilenya can alter the way the body's immune system works and is used to treat relapsing remitting multiple sclerosis (MS) and relapses in patients with secondary progressive multiple sclerosis.
Gilenya slows down the progression of physical disability and decreases the number of flare-ups (relapses) in patients with some relapsing forms of MS.
Gilenya helps to fight against attacks of the immune system by affecting the ability of some white blood cells to move freely within the body and by stopping the cells that cause inflammation from reaching the brain. This reduces nerve damage caused by MS. Gilenya may also have a direct and beneficial effect on certain brain cells (neural cells) involved in repairing or slowing down the damage of MS.
Ask your doctor if you have any questions about how Gilenya works or why this medicine has been prescribed for you.
This medicine is only available with a doctor's prescription. It is not addictive.
There is not enough information to recommend this medicine for children.
Experience with Gilenya in older people (more than 65 years old) is limited. Talk to your doctor if you have any concerns.
Before you take Gilenya
When you must not take it
Do not take Gilenya if you have an allergy to:
fingolimod (the active ingredient) or to any of the other ingredients listed at the end of this leaflet
any other similar medicines (such as medicines of the same class or with a similar structure).
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.
Your doctor will want to know if you are prone to allergies.
Tell your doctor if you are pregnant, think you might be pregnant, or are trying to become pregnant.
You should avoid becoming pregnant while taking Gilenya or in the two months after you stop taking it because Gilenya may harm your unborn baby.
If you do become pregnant while taking Gilenya tell your doctor right away. You and your doctor will decide what is best for you and your baby.
You should not breast-feed while you are taking Gilenya.
Gilenya can pass into breast milk and there is a risk of serious side effects for a breast-fed baby. Talk with your doctor before breast-feeding while you take Gilenya.
Tell your doctor if y